Feasibility of the UriCap-F for Urine Collection in Hospitalized Women

NCT02530372 | Unknown

• 1 other identifier: GRD-01F
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study will evaluate safety and effectiveness of the UriCap-F, a non-invasive urine collection device for women, in hospitalized patients who would otherwise be treated with an indwelling catheter, pads or diapers.

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (6)

• Number of Adverse Device Events

  1-30 days

• Use Safety as demonstrated by System Usability Score assessed by healthcare providers

  1 week

• Effectiveness of the device to collect urine

  Multiple variables will be assessed and their measurements aggregated to arrive at a number of events reported: * Leakage * Pooling of urine in the tubing * Tubing disconnections * Adhesive tape disconnections * Need for repositioning of device * Device malfunctions

  1-30 days

• Patient satisfaction in device use

  Overall treatment satisfaction will be assessed by means of a "Treatment Satisfaction Questionnaire" administered at termination of device use.

  1-30 days

• Healthcare provider (HCP) satisfaction

  Treatment satisfaction will be assessed by means of a "Treatment Satisfaction Questionnaire" administered after termination of all study patients

  up to 60 days

• Patient Comfort

  Comfort will be assessed by means of the "Universal Pain Assessment Scale" of 1-10, At every device application, every removal, and when patient complains of discomfort or pain.

  1-30 days

Secondary Outcomes (2)

• Effectiveness of defined device cleaning procedure for reuse

  1-30 days

• Leakage as a result of device movement

  1-30 days

Study Arms (1)

UriCap-F

EXPERIMENTAL

The UriCap-F is an FDA cleared Class I device intended for urinary management in women. The device is comprised of a multiple use unit and a single use unit. The multiple use unit is intended to be reused by the same patient for up to 30 days. It is removed every 24 hours, rinsed under running water, dried and re-applied. The UriCap is held in position by means of a single-use medically approved adhesive tape.

Device: UriCap-F

Interventions

UriCap-F DEVICE

non-invasive urine collection device for women

UriCap-F

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female ≥ 18 years old
• Empties the bladder completely on voiding
• A clinical indication for an indwelling catheter, use of pads or diapers
• Patient has signed an informed consent form, is cooperative and willing to complete all study procedures
• Absence of localized disease at the site of device application - vaginal discharge, itching, inflammation or skin condition
• Agrees to genital hair removal.

You may not qualify if:

• Pregnant or breastfeeding
• Menstruation at time of enrolment
• Known allergy to silicon
• Dysuria
• Urinary retention - Post-void residual urine more than 300cc
• Hematuria or pyuria (turbidity) on visual inspection, according to investigator judgement.
• Diagnosed with acute renal failure according, to investigator judgement.
• Serious or unstable psychological condition (e.g., eating disorders, clinical depression, anxiety, emotionally labile) which, in the opinion of the Investigator, would compromise the patient's well-being or successful participation in the study
• Participating in another clinical study.
• Financial interest in the Sponsor Company or a competitor company by patient or a family member

Sponsors & Collaborators

• G.R. Dome Medical Ltd.: lead

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Elad Schiff, MD

  No affiliation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2015
• First Posted: August 21, 2015
• Study Start: September 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: September 18, 2015

Record last verified: 2015-09